Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT01491802
Status:
COMPLETED
Last Update Posted:
2017-08-15
First Post:
2011-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of a New Combination Bronchodilator on Exercise in GOLD Stage II Moderate COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D004417', 'term': 'Dyspnea'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C573971', 'term': 'GSK573719'}, {'id': 'C550468', 'term': 'vilanterol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kw2@queensu.ca', 'phone': '613-549-6666', 'title': 'Kathy Webb', 'phoneExt': '4950', 'organization': "Queen's University"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Over the duration of the study (approximately 12 weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'LAMA Arm', 'description': 'The 4-week treatment period with once daily inhaled umeclidinium (125 mcg).', 'otherNumAtRisk': 17, 'otherNumAffected': 1, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LABA/LAMA Arm', 'description': 'The 4-week treatment period with once daily inhaled fixed-dose combination of umeclidinium (125 mcg) and vilanterol (25 mcg).', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Washout Period', 'description': 'There was a 2 week washout period between the two treatment arms.', 'otherNumAtRisk': 17, 'otherNumAffected': 1, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COPD exacerbation', 'notes': 'An exacerbation of COPD requiring treatment (oral steroids and/or antibiotic).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Exertional Dyspnea Intensity at Isotime Exercise.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAMA', 'description': 'GSK573719 is a long-acting muscarinic antagonist\n\nGSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks'}, {'id': 'OG001', 'title': 'LABA/LAMA Combination', 'description': 'GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.\n\nGSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.090', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Intensity of dyspnea (defined as breathing discomfort) at a standardized time (isotime) during constant work rate exercise tests as measured by the modified 10-point Borg scale. A rating of 0 represents no dyspnea up to a maximum of 10: a smaller rating is therefore an improvement. Isotime was defined as the highest exercise time in minutes completed in both post-treatment tests.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 17 randomized subjects, 3 subjects were withdrawn (2 AEs, 1 withdrawn consent ) leaving 14 completed subjects for analysis.'}, {'type': 'SECONDARY', 'title': 'Exercise Endurance Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAMA', 'description': 'GSK573719 is a long-acting muscarinic antagonist\n\nGSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks'}, {'id': 'OG001', 'title': 'LABA/LAMA Combination', 'description': 'GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.\n\nGSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.82', 'spread': '6.15', 'groupId': 'OG000'}, {'value': '7.49', 'spread': '4.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.680', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Duration of constant work rate cycle exercise at 75% of maximum', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Inspiratory Capacity at Rest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAMA', 'description': 'GSK573719 is a long-acting muscarinic antagonist\n\nGSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks'}, {'id': 'OG001', 'title': 'LABA/LAMA Combination', 'description': 'GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.\n\nGSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.27', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '0.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.197', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Measurements of pulmonary function included spirometry and body plethysmography. The resting inspiratory capacity (IC) values reported here are 90 minutes post-dose after 4 weeks of treatment.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 subjects completed both treatments for comparison.'}, {'type': 'SECONDARY', 'title': 'Ventilation at Isotime Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAMA', 'description': 'GSK573719 is a long-acting muscarinic antagonist\n\nGSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks'}, {'id': 'OG001', 'title': 'LABA/LAMA Combination', 'description': 'GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.\n\nGSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.9', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '47.5', 'spread': '18.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Ventilation was measured during constant work rate exercise tests. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 subjects completed both treatment arms for comparison.'}, {'type': 'SECONDARY', 'title': 'Intensity of "Unpleasantness of Breathing" at Isotime Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAMA', 'description': 'GSK573719 is a long-acting muscarinic antagonist\n\nGSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks'}, {'id': 'OG001', 'title': 'LABA/LAMA Combination', 'description': 'GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.\n\nGSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.044', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Intensity rating (modified 10-point Borg scale) measured at a standardized time (isotime) during constant work rate exercise tests. A rating of 0 represents no "unpleasantness of breathing" up to a maximum of 10. An improvement would be noted as a decrease in the Borg scale rating. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 17 randomized subjects, 3 subjects were withdrawn (2 AEs, 1 withdrawn consent ) leaving 14 completed subjects for analysis.'}, {'type': 'SECONDARY', 'title': 'Inspiratory Capacity at Isotime Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAMA', 'description': 'GSK573719 is a long-acting muscarinic antagonist\n\nGSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks'}, {'id': 'OG001', 'title': 'LABA/LAMA Combination', 'description': 'GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.\n\nGSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '2.02', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.573', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Measurements of inspiratory capacity (IC) were conducted during constant work rate exercise tests. Isotime was defined as the highest time in minutes completed in both post-treatment tests.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 subjects completed both treatment arms for comparison.'}, {'type': 'SECONDARY', 'title': 'Diaphragm Electromyogram (EMGdi) at Isotime Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAMA', 'description': 'GSK573719 is a long-acting muscarinic antagonist\n\nGSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks'}, {'id': 'OG001', 'title': 'LABA/LAMA Combination', 'description': 'GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.\n\nGSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '53.5', 'spread': '13.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.960', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'EMGdi was measured during constant work rate exercise tests via a multipair-electrode esophageal catheter. EMGdi expressed as a percentage of its maximum is used as an index of inspiratory neural drive. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.', 'unitOfMeasure': 'percentage of maximum EMGdi', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although 14 subjects completed both treatment arms, only 9 subjects had complete measurements of EMGdi and respiratory pressures.'}, {'type': 'SECONDARY', 'title': 'Tidal Esophageal Pressure (Pes) Swings at Isotime Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAMA', 'description': 'GSK573719 is a long-acting muscarinic antagonist\n\nGSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks'}, {'id': 'OG001', 'title': 'LABA/LAMA Combination', 'description': 'GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.\n\nGSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'spread': '17', 'groupId': 'OG000'}, {'value': '28', 'spread': '20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.944', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Tidal esophageal pressure (Pes) swings were measured via an esophageal balloon catheter during constant work rate exercise tests. Tidal Pes expressed relative to maximum is an index of respiratory effort. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.', 'unitOfMeasure': 'percentage of maximum Pes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Although 14 subjects completed both treatment arms for comparison, only 9 subjects also had complete measurements of EMGdi and respiratory pressures.'}, {'type': 'SECONDARY', 'title': 'Mean Expiratory Flow at Isotime Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAMA', 'description': 'GSK573719 is a long-acting muscarinic antagonist\n\nGSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks'}, {'id': 'OG001', 'title': 'LABA/LAMA Combination', 'description': 'GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.\n\nGSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.19', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '2.34', 'spread': '0.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'A paired t-test using a 2-sided test of significance was used to compare values after LAMA versus LABA/LAMA treatment.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Mean expiratory flow was measured during constant work rate exercise tests. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.', 'unitOfMeasure': 'L/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 subjects completed both treatment arms for comparison.'}, {'type': 'SECONDARY', 'title': 'Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LAMA', 'description': 'GSK573719 is a long-acting muscarinic antagonist\n\nGSK573719: GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks'}, {'id': 'OG001', 'title': 'LABA/LAMA Combination', 'description': 'GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy.\n\nGSK573719/GW642444: GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.56', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '1.72', 'spread': '0.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'Measurements of pulmonary function included spirometry and body plethysmography. Values reported are 90 minutes post-dose after 4 weeks of treatment.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '14 subjects completed both treatments for comparison.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LAMA, Then LAMA/LABA', 'description': 'Participants first received LAMA alone (umeclidinium 125 mcg) once daily for 4 weeks. After a 2 week washout period, they received the LAMA/LABA combination product (umeclidinium 125 mcg plus vilanterol 25 mcg) once daily for 4 weeks.'}, {'id': 'FG001', 'title': 'LAMA/LABA, the LAMA', 'description': 'Participants first received the LAMA/LABA combination product (umeclidinium 125 mcg plus vilanterol 25 mcg) once daily for 4 weeks. After a 2 week washout period, they received LAMA alone (umeclidinium 125 mcg) once daily for 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled between March 2012 and June 2014.', 'preAssignmentDetails': 'There was run-in period of approximately 2 weeks for determination of eligibility and familiarization with all tests to be performed during subsequent treatment visits. There was a 2-week washout period between each 4-week treatment period of this crossover study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Randomized Subjects', 'description': 'All 17 randomized subjects.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'FEV1 %predicted', 'classes': [{'categories': [{'measurements': [{'value': '70.9', 'spread': '69.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Post-bronchodilator measurement', 'unitOfMeasure': '% of predicted normal', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1/FVC % ratio', 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'spread': '7.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Post-bronchodilator measurement', 'unitOfMeasure': '%', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking history', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pack-years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline Dyspnea Index score', 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '1.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Scoring range for activity-related dyspnea is 0 (most severe) to 12 (none).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2011-12-12', 'resultsFirstSubmitDate': '2016-12-13', 'studyFirstSubmitQcDate': '2011-12-13', 'lastUpdatePostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-02', 'studyFirstPostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exertional Dyspnea Intensity at Isotime Exercise.', 'timeFrame': '4 weeks', 'description': 'Intensity of dyspnea (defined as breathing discomfort) at a standardized time (isotime) during constant work rate exercise tests as measured by the modified 10-point Borg scale. A rating of 0 represents no dyspnea up to a maximum of 10: a smaller rating is therefore an improvement. Isotime was defined as the highest exercise time in minutes completed in both post-treatment tests.'}], 'secondaryOutcomes': [{'measure': 'Exercise Endurance Time', 'timeFrame': '4 weeks', 'description': 'Duration of constant work rate cycle exercise at 75% of maximum'}, {'measure': 'Inspiratory Capacity at Rest', 'timeFrame': '4 weeks', 'description': 'Measurements of pulmonary function included spirometry and body plethysmography. The resting inspiratory capacity (IC) values reported here are 90 minutes post-dose after 4 weeks of treatment.'}, {'measure': 'Ventilation at Isotime Exercise', 'timeFrame': '4 weeks', 'description': 'Ventilation was measured during constant work rate exercise tests. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.'}, {'measure': 'Intensity of "Unpleasantness of Breathing" at Isotime Exercise', 'timeFrame': '4 weeks', 'description': 'Intensity rating (modified 10-point Borg scale) measured at a standardized time (isotime) during constant work rate exercise tests. A rating of 0 represents no "unpleasantness of breathing" up to a maximum of 10. An improvement would be noted as a decrease in the Borg scale rating. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.'}, {'measure': 'Inspiratory Capacity at Isotime Exercise', 'timeFrame': '4 weeks', 'description': 'Measurements of inspiratory capacity (IC) were conducted during constant work rate exercise tests. Isotime was defined as the highest time in minutes completed in both post-treatment tests.'}, {'measure': 'Diaphragm Electromyogram (EMGdi) at Isotime Exercise', 'timeFrame': '4 weeks', 'description': 'EMGdi was measured during constant work rate exercise tests via a multipair-electrode esophageal catheter. EMGdi expressed as a percentage of its maximum is used as an index of inspiratory neural drive. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.'}, {'measure': 'Tidal Esophageal Pressure (Pes) Swings at Isotime Exercise', 'timeFrame': '4 weeks', 'description': 'Tidal esophageal pressure (Pes) swings were measured via an esophageal balloon catheter during constant work rate exercise tests. Tidal Pes expressed relative to maximum is an index of respiratory effort. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.'}, {'measure': 'Mean Expiratory Flow at Isotime Exercise', 'timeFrame': '4 weeks', 'description': 'Mean expiratory flow was measured during constant work rate exercise tests. Isotime was defined as the highest exercise time in minutes common to both post-treatment tests.'}, {'measure': 'Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': '4 weeks', 'description': 'Measurements of pulmonary function included spirometry and body plethysmography. Values reported are 90 minutes post-dose after 4 weeks of treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD', 'Combination therapy', 'Anticholinergic', 'Beta2-agonist', 'Exercise', 'Dyspnea', 'Respiratory mechanics'], 'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': 'Preliminary information from our laboratory indicated that even patients with milder chronic obstructive pulmonary disease (COPD) can have significant physiological derangements which become more pronounced during exercise, leading to intolerable dyspnea at lower levels of ventilation than in health. This study will explore pathophysiological mechanisms of dyspnea and activity limitation in GOLD stage II COPD and will determine if there is a sound physiological rationale for the use of dual long-acting beta2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) therapy (GSK573719/ GW642444 Inhalation Powder) versus LAMA alone (GSK573719) as treatment for dyspnea and exercise intolerance in this subpopulation. Objectives of this study are to determine if: 1) neuromechanical uncoupling of the respiratory system contributes to exertional dyspnea in milder COPD, and 2) treatment with LABA/LAMA improves dyspnea and exercise endurance compared with LAMA by improving neuromechanical coupling. The investigators hypothesize that: 1) dyspnea is related to excessive dynamic lung hyperinflation, tidal volume restriction and increased ratio of central respiratory neural drive to tidal volume displacement, a measure of neuromechanical uncoupling of the respiratory system, and 2) LABA/LAMA will improve dyspnea and exercise endurance, which will be explained by partial reversal of the above mechanical abnormalities. The investigators will conduct a randomized, double-blind crossover study and compare the effects of once-daily LABA/LAMA over 4-weeks with LAMA on dyspnea, exercise endurance and ventilatory mechanics in GOLD stage II COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable moderate COPD\n* Post-bronchodilator FEV1/FVC\\<0.7 and 50%≤FEV1\\<80% predicted\n* Baseline Dyspnea Index ≤ 9 and MRC dyspnea scale \\>2\n* Cigarette smoking history at least 20 pack-years\n\nExclusion Criteria:\n\n* Presence of a significant disease other than COPD that could contribute to dyspnea and exercise limitation\n* Important contraindications to clinical exercise testing\n* Use of daytime oxygen\n* History of asthma'}, 'identificationModule': {'nctId': 'NCT01491802', 'briefTitle': 'Effect of a New Combination Bronchodilator on Exercise in GOLD Stage II Moderate COPD', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'A 4-week Randomized, Double-blind, Crossover Study to Assess the Effect of a New LABA/LAMA Combination Versus LAMA Alone on Exertional Dyspnea, Exercise Endurance and Neuromechanical Coupling in Patients With GOLD Stage II COPD', 'orgStudyIdInfo': {'id': 'DMED-1426-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAMA alone, then LAMA/LABA combination', 'description': 'Participants will first receive an inhaled long-acting muscarinic antagonist (LAMA) once daily for 4 weeks. After a 2 week washout period, they will then receive the fixed-dose combination product \\[LAMA plus long-acting beta2-agonist (LABA)\\] once daily for 4 weeks.', 'interventionNames': ['Drug: LAMA/LABA', 'Drug: LAMA']}, {'type': 'EXPERIMENTAL', 'label': 'LABA/LAMA combination, then LAMA alone', 'description': 'Participants will first receive a long-acting muscarinic antagonist (LAMA) plus long-acting beta2-agonist (LABA) combination product once daily for 4 weeks. After a 2 week washout period, they will then receive the LAMA single product once daily for 4 weeks.', 'interventionNames': ['Drug: LAMA/LABA', 'Drug: LAMA']}], 'interventions': [{'name': 'LAMA/LABA', 'type': 'DRUG', 'otherNames': ['GSK573719+GW642444', 'umeclidinium (GSK573719) / vilanterol (GW642444)', 'Anoro ELLIPTA'], 'description': 'GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.', 'armGroupLabels': ['LABA/LAMA combination, then LAMA alone', 'LAMA alone, then LAMA/LABA combination']}, {'name': 'LAMA', 'type': 'DRUG', 'otherNames': ['umeclidinium'], 'description': 'GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks', 'armGroupLabels': ['LABA/LAMA combination, then LAMA alone', 'LAMA alone, then LAMA/LABA combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Respiratory Investigation Unit at Kingston General Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': "Denis E O'Donnell, MD, FRCPC", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University and Kingston General Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': "Dr. Denis O'Donnell", 'investigatorAffiliation': "Queen's University"}}}}